Acute Ischemic Stroke Clinical Trial
Official title:
Dynamic Changes of Vascular Endothelial Growth Factor and Endostatin in Association With Circulating Endothelial Progenitor Cells After Acute Ischemic Stroke
| NCT number | NCT02157896 |
| Other study ID # | H1583-660110 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2013 |
| Est. completion date | May 2014 |
| Verified date | August 2020 |
| Source | Shanghai 6th People's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Vascular endothelial growth factor (VEGF) and Endostatin (ES) participate angiogenesis after cerebral ischemia. Circulating endothelial progenitor cells (EPCs) also play a crucial role in neovascularization and tissue repair after acute ischemic stroke (AIS). The investigators sought to compare the expression of VEGF and ES in serum and the circulating EPCs in patients after AIS with that of healthy control subjects. The investigators obtained peripheral blood and serum samples from study subjects. EPCs in blood samples from AIS patients and healthy controls were quantified by flow cytometry 1 day, 3 days, 5 days and 7 days after AIS. VEGF and ES were measured by enzyme linked immunosorbent assay at the same time points. The relation between them and the relation of them to prognosis of such patients with acute ischemic stroke were assessed.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | May 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 45 Years to 74 Years |
| Eligibility |
Inclusion Criteria: - Clinical diagnosis of acute ischemic stroke - Admission within 12 hours - National Institutes of Health Stroke Scale score 6-25 Exclusion Criteria: - Lacunar infarction - Cerebral hemorrhagic infarction - Epilepsy or epileptic persons - History of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases - Contraindications to antiplatelet treatments - Died within the first week of hospitalization - Serial blood samples could not be obtained |
| Country | Name | City | State |
|---|---|---|---|
| China | Shanghai Sixth People's Hospital | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai 6th People's Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Modified Rankin Scale scores | 0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate - Page 3 of 4 [DRAFT] - disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead. |
3 months | |
| Secondary | Glasgow Outcome Scale scores | Glasgow Outcome Scale 1 = death; Glasgow Outcome Scale 2 = vegetative state; Glasgow Outcome Scale 3 = severe neurological deficit; Glasgow Outcome Scale 4 = mild neurological deficit and Glasgow Outcome Scale 5 = premorbid level of functioning or completely recovery. | 3 months |
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